Paddle lead configurations for electrical stimulation systems and methods of making and using

ABSTRACT

A paddle lead includes a paddle body with a plurality of electrodes disposed on the paddle body. The plurality of electrodes includes a first electrode and a second electrode. The first electrode and the second electrode are disposed laterally around the circumference of the paddle body. At least one connecting wire is disposed on, or within, the paddle body to electrically couple the first electrode and the second electrode.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationsystems that include a paddle lead with an array of electrodes disposedon the paddle lead, as well as methods of making and using the systems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Deep brain stimulation has also been useful fortreating refractory chronic pain syndromes and has been applied to treatmovement disorders and epilepsy. Peripheral nerve stimulation has beenused to treat chronic pain syndrome and incontinence, with a number ofother applications under investigation. Functional electricalstimulation systems have been applied to restore some functionality toparalyzed extremities in spinal cord injury patients. Moreover,electrical stimulation systems can be implanted subcutaneously tostimulate subcutaneous tissue including subcutaneous nerves such as theoccipital nerve.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

In one embodiment, a paddle lead includes a paddle body with a pluralityof electrodes disposed on the paddle body. The plurality of electrodesincludes a first electrode and a second electrode. The first electrodeand the second electrode are disposed laterally around the circumferenceof the paddle body. At least one connecting wire is disposed on, orwithin, the paddle body to electrically couple the first electrode andthe second electrode.

In another embodiment, a paddle lead includes a lead body for couplingthe paddle lead to one or more external devices. The paddle lead alsoincludes a paddle body distal to the lead body. The paddle body includesa plurality of electrodes disposed on the paddle body. The plurality ofelectrodes forms at least one lateral loop around the circumference ofthe paddle body.

Yet another embodiment is a method of using a paddle lead. The methodincludes implanting a paddle lead into a body. The paddle lead includesa paddle body and a plurality of electrodes disposed on the paddle body.The paddle lead also includes a plurality of electrodes, including afirst electrode and a second electrode. The first electrode and thesecond electrode are disposed laterally around the circumference of thepaddle body. The paddle lead further includes at least one connectingwire disposed on, or within, the paddle body to electrically couple thefirst electrode and the second electrode. The method also includescoupling the paddle lead to a control module and stimulating tissue nearthe paddle lead using two or more of the electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system, according to the invention;

FIG. 2A is a schematic cross-sectional view of one embodiment of apaddle body for use in an electrical stimulation system, according tothe invention;

FIG. 2B is a schematic cross-sectional view of another embodiment of apaddle body for use in an electrical stimulation system, according tothe invention.

FIG. 3 is a schematic cross-sectional/perspective view of one embodimentof a paddle body for use in an electrical stimulation system, accordingto the invention;

FIG. 4A is a schematic cross-sectional/perspective view of anotherembodiment of a paddle body for use in an electrical stimulation system,according to the invention;

FIG. 4B is a schematic cross-sectional/perspective view of theembodiment of the paddle body shown in FIG. 4A with electrodes in bothcoupled arrangements and non-coupled arrangements for use in anelectrical stimulation system, according to the invention;

FIG. 5A is a schematic cross-sectional/perspective view of a thirdembodiment of a paddle body for use in an electrical stimulation system,according to the invention;

FIG. 5B is a schematic cross-sectional/perspective view of the paddlebody shown in FIG. 5A with single-sided coupled arrangements for use inan electrical stimulation system, according to the invention;

FIG. 6 is a schematic cross-sectional/perspective view of a fourthembodiment of a paddle body for use in an electrical stimulation system,according to the invention;

FIG. 7A is a schematic cross-sectional/perspective view of a fifthembodiment of a paddle body for use in an electrical stimulation system,according to the invention;

FIG. 7B is a schematic cross-sectional/perspective view of theembodiment of the paddle body shown in FIG. 7A with electrodes in bothcoupled arrangements and non-coupled arrangements for use in anelectrical stimulation system, according to the invention;

FIG. 8 is a schematic cross-sectional/perspective view of a sixthembodiment of a paddle body for use in an electrical stimulation system,according to the invention;

FIG. 9 is a schematic cross-sectional/perspective view of a seventhembodiment of a paddle body for use in an electrical stimulation system,according to the invention;

FIG. 10A is a schematic cross-sectional/perspective view of anembodiment of a coupled arrangement forming a lateral loop on a paddlebody for use in an electrical stimulation system, according to theinvention;

FIG. 10B is a schematic cross-sectional/perspective view of anembodiment of a coupled arrangement forming two lateral loops on apaddle body for use in an electrical stimulation system, according tothe invention;

FIG. 10C is a schematic cross-sectional/perspective view of anembodiment of a coupled arrangement forming three lateral loops on apaddle body for use in an electrical stimulation system, according tothe invention;

FIG. 11 is a schematic cross-sectional/perspective view of an embodimentof a paddle body with various coupled arrangements and non-coupledarrangements for use in an electrical stimulation system, according tothe invention;

FIG. 12 is a schematic overview of one embodiment of components of astimulation system 1200 including an electronic subassembly 1210disposed within a control module.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationsystems that include a paddle lead with an array of electrodes disposedon the paddle lead, as well as methods of making and using the systems.

Suitable implantable stimulation systems include, but are not limitedto, an electrode lead with one or more electrodes disposed on a distalend of the lead and one or more terminals disposed on a proximal end ofthe lead. Electrical leads include, for example, paddle leads. Examplesof stimulation systems with electrode leads are found in, for example,U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; and U.S.patent application Ser. No. 10/335,101, now U.S. Pat. No. 6,787,414,issued on Aug. 19, 2004; Ser. No. 10/509,281, now U.S. Pat. No.7,61,981, issued on Jan. 6, 2010; Ser. No. 11/238,240, now U.S. Pat. No.7,761,165, issued on Jul. 20, 2010; Ser. No. 11/319,291, still pending;Ser. No. 11/327,880, now U.S. Pat. No. 7,244,150, issued on Jul. 17,2007; Ser. No. 11/375,638, now U.S. Pat. No. 8,175,710, issued on May 8,2012; Ser. No. 11/393,991, now U.S. Pat. No. 7,974,706, issued on Jul.2, 2011 and Ser. No. 11/396,309 now U.S. Pat. No. 7,672,734, issued onMar. 2, 2010, all of which are incorporated by reference.

FIG. 1 illustrates schematically one embodiment of a stimulation system100. The stimulation system includes a control module (e.g., astimulator or pulse generator) 102, a paddle body 104, and at least onelead body 106 coupling the control module to the paddle body. The paddlebody 104 and the lead body 106 form a paddle lead. The paddle body 104typically includes an array of electrodes 134. The control module 102typically includes an electronic subassembly 110 and optional powersource 120 disposed in a sealed housing 114. The control module 102typically includes a port (not shown) into which the proximal end of thelead body 106 can be plugged to make an electrical connection viaconnective contacts in the control module and contact terminals on thelead body. It will be understood that the system for stimulation caninclude more, fewer, or different components including thoseconfigurations disclosed in the stimulation system references citedherein. For example, one or more lead extensions (not shown in FIG. 1)can be disposed between the control module and the paddle body to extendthe distance between the control module and the paddle body.

The stimulation system or components of the stimulation system,including one or more of the lead body 106, the paddle body 104, and thecontrol module 102, are typically implanted into the body. Thestimulation system can be used for a variety of applications including,but not limited to, brain stimulation, neural stimulation, spinal cordstimulation, muscle stimulation, and the like.

The electrodes 134 can be made using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. The number of electrodes 134 in the array ofelectrodes 134 may vary. For example, there can be two, four, six,eight, ten, twelve, fourteen, sixteen, twenty, twenty-four,twenty-eight, thirty-two, thirty-six, or more electrodes 134. As will berecognized, other numbers of electrodes 134 may also be used.

The electrodes of the paddle body 104 or lead body 106 are typicallydisposed in a non-conductive, biocompatible material including, forexample, silicone, polyurethane, polyetheretherketone (PEEK), epoxy, andthe like or combinations thereof. The paddle body 104 and lead body 106may be formed in the desired shape by any process including, forexample, molding (including injection molding), casting, and the like.The non-conductive material typically extends from the distal end of thelead to the proximal end. The non-conductive, biocompatible material ofthe paddle body 104 and the lead body 106 may be the same or different.The paddle body 104 and lead body 106 may be a unitary structure or canbe formed as two separate structures that are permanently or detachablycoupled together.

Contact terminals (not shown in FIG. 1) are typically disposed at theproximal end of the lead for connection to corresponding conductivecontacts in the control module 102 (or to conductive contacts on a leadextension). Conductive wires (not shown in FIG. 1) extend from thecontact terminals to the electrodes 134. Typically, one or moreelectrodes are electrically connected to a contact. In some embodiments,each contact terminal is only connected to one electrode. The conductivewires may be embedded in the non-conductive material of the lead or canbe disposed in one or more lumens extending along the lead. In someembodiments, there is an individual lumen for each conductive wire. Inother embodiments, two or more conductive wires may extend through alumen. There may also be one or more lumens that open at, or near, thedistal end of the lead, for example, for infusion of drugs or medicationinto the side of implantation of the paddle body.

FIG. 2A is a schematic cross-sectional view of one embodiment of apaddle body for use in an electrical stimulation system, according tothe invention. In at least some embodiments, a paddle body 202 can havean ellipse-like cross-section with a major axis 204, indicated in FIG.2A by a two-headed dashed arrow, and a minor axis 206, indicated in FIG.2A by a two-headed dashed arrow orthogonal to the major axis 204. Thelength of the major axis 204 is greater than the length of the minoraxis 206. The major axis 204 is typically longer than the minor axis206. For example, the major axis 204 can be at least four times thelength of the minor axis 206, at least five times the length of theminor axis 206, at least six times the length of the minor axis 206, atleast eight times the length of the minor axis 206, at least ten timesthe length of the minor axis 206. As will be recognized, other relativelengths of the axes 204 and 206 may also be used. FIG. 2B is a schematiccross-sectional view of another embodiment of a paddle body for use inan electrical stimulation system, according to the invention. In otherembodiments, a paddle body 208 can have a rounded-edged-rectangular-likecross-section with a major axis 210 and a minor axis 212 orthogonal tothe major axis 210 and with a length that is less than the length of themajor axis 210.

FIG. 3 is a schematic cross-sectional/perspective view of one embodimentof a paddle body for use in an electrical stimulation system, accordingto the invention. The paddle body 104 includes two opposing majorsurfaces: an anterior surface 302; and an inferior surface 304. In oneembodiment, the widths of the anterior surface 302 and the inferiorsurface 304 are determined, at least in part, by the length of the majoraxis (204 in FIG. 2). An array of electrodes 134 includes a plurality ofelectrodes, such as electrode 306, and is disposed on both the anteriorsurface 302 and the inferior surface 304. Each electrode shown in FIG. 3is a unitary structure and forms a continuous lateral loop around thecircumference of the paddle body 104.

In at least some embodiments, electrodes are coupled electrically to oneor more conductive wires that extend from the paddle body to one or morecontact terminals on a proximal end of the lead. As discussed above, theconductive wires may be embedded in the non-conductive material of thelead or can be disposed in one or more lumens extending along the lead.In some embodiments, there is an individual lumen for each conductivewire. In other embodiments, two or more conductive wires may extendthrough a lumen.

One advantage of the two-sided electrode arrangement on the paddle bodyshown in FIG. 3 over conventional one-sided electrode arrangements onconventional paddle bodies is that, with a two-sided electrodearrangement, a lead may be implanted without regard to which side of thecorresponding paddle body is facing anteriorly in the body of animplantee. Thus, a health care professional implanting a stimulationsystem may perform the implantation with fewer concerns about paddlebody orientation. Another advantage of the paddle arrangement of thisembodiment is that simultaneous multidirectional stimulation may beachieved, if desired. Multidirectional stimulation may provide a numberof therapeutic benefits, such as providing relief of peripheral pain. Insome body regions, such as peripheral regions, a paddle lead may be moretolerated than a percutaneous lead. Thus, the paddle arrangement of thisembodiment allows for the use of a paddle lead, which is typically moretolerated than a percutaneous lead, while also providingmultidirectional stimulation.

It may be desirable to increase the flexibility of a paddle body.Increased flexibility may facilitate implantation of a paddle body byincreasing maneuverability. One method of increasing flexibility is tosubstitute a unitary electrode forming a lateral loop around theperiphery of a paddle body with a plurality of electrically-coupledelectrodes forming a lateral loop around the periphery of a paddle body.The electrodes forming the lateral loop may be electrically coupledtogether by connecting wires disposed around the periphery of a paddlebody or inside the paddle body. In at least some embodiments, connectingwires for lateral loops electrically coupled together by connectingwires disposed around the periphery of a paddle body are actually justbelow the surface of the paddle body and do not contact patient tissue.

FIG. 4A is a schematic cross-sectional/perspective view of anotherembodiment of a paddle body for use in an electrical stimulation system,according to the invention. In FIG. 4A, a first electrode 402 disposedon the anterior surface 302 is electrically coupled to a secondelectrode 404 disposed on the inferior surface 304 by peripheralconnecting wires 406 and 408 extending laterally around the surface ofthe paddle body 104. The peripheral connecting wires 406 and 408 areeach disposed on both the anterior surface 302 and the inferior surface304 of the paddle body 104. Collectively, the first electrode 402, thesecond electrode 404, and the two peripheral connecting wires 406 and408 form a coupled arrangement 410. An electrode array 134 includes anumber of similar laterally-extending coupled arrangements disposedalong a longitudinal axis of the paddle body 104.

An electrode in a coupled arrangement has a cross-sectional area that ismuch larger in size than a coupled peripheral connecting wire in thecoupled arrangement. The cross-sectional area of an electrode in acoupled arrangement can be larger than the cross-sectional area of aperipheral connecting wire by different amounts. For example, anelectrode can have a cross-sectional area that is at least two timeslarger than the cross-sectional of a peripheral connecting wire, atleast five times larger than the cross-sectional area of a peripheralconnecting wire, at least ten times larger than the cross-sectional areaof a peripheral connecting wire, at least fifteen times larger than thecross-sectional area of a peripheral connecting wire, at least twentytimes larger than the cross-sectional area of a peripheral connectingwire, at least fifty times larger than the cross-sectional area of aperipheral connecting wire, at least one hundred times larger than thecross-sectional area of a peripheral connecting wire, or thecross-sectional area of an electrode in a coupled arrangement can belarger than the cross-sectional area of a peripheral connecting wire bylarger amounts. As will be recognized, other relative cross-sectionalareas may also be used.

The electrodes and peripheral connecting wires may be fabricated fromany of a number of suitable conductive materials that are eitherflexible or nonflexible, including metals, alloys, conductive polymers,conductive carbon, and the like, as well as combinations thereof. Theconductive materials used to fabricate the electrodes and the peripheralconnecting wire may be the same or different.

A paddle body may contain an electrode array that includes one or morecoupled arrangements and one or more electrodes that do not form acoupled arrangement. FIG. 4B is a schematic cross-sectional/perspectiveview of the embodiment of the paddle body shown in FIG. 4A withelectrodes in both coupled arrangements and non-coupled arrangements foruse in an electrical stimulation system, according to the invention. InFIG. 4B, the coupled arrangement 410 extends laterally around theperiphery of paddle body 104. Likewise, coupled arrangement 414 includesa third electrode 412 disposed on the anterior surface, a fourthelectrode (not shown in FIG. 4B) disposed on the inferior side 304, andtwo peripheral connecting wires electrically coupling the thirdelectrode and the fourth electrode. However, the paddle body 104 alsoincludes a fifth electrode 416 disposed on the anterior side 302 that isnot coupled to a corresponding electrode on the inferior side 304.

A coupled arrangement may use additional electrodes and connecting wiresto extend laterally around the periphery of a paddle body. FIG. 5A is aschematic cross-sectional/perspective view of a third embodiment of apaddle body for use in an electrical stimulation system, according tothe invention. In FIG. 5A, a coupled arrangement 502 includes twoelectrodes 504 and 506 on the anterior surface 302, two electrodes 508and 510 on the inferior surface 304, and peripheral connecting wires512-515 electrically coupling each of the four electrodes 504, 506, 508,and 510 and extending laterally around the periphery of the paddle body104. A number of similar laterally-extending coupled arrangementsdisposed along a longitudinal axis of the paddle body 104 createelectrode array 134.

A coupled arrangement may include two or more electrodes electricallycoupled in a lateral direction by one or more peripheral connectingwires without forming a lateral loop. Additionally coupled arrangementscan be disposed on either an anterior side or an inferior side of apaddle body without also being disposed on the opposing side. FIG. 5B isa schematic cross-sectional/perspective view of the paddle body shown inFIG. 5A with single-sided coupled arrangements for use in an electricalstimulation system, according to the invention. In FIG. 5B, a coupledarrangement 516 is disposed on the anterior surface 302 of the paddlebody 104 and includes a peripheral connecting wire 518 electricallycoupling a first electrode 520 and a second electrode 522. In otherembodiments, a coupled arrangement is disposed laterally on an inferiorsurface of a paddle body. In yet other embodiments, a coupledarrangement is disposed laterally on both an anterior and an inferiorsurface without forming a lateral loop.

FIG. 6 is a schematic cross-sectional/perspective view of a fourthembodiment of a paddle body for use in an electrical stimulation system,according to the invention. In FIG. 6, a coupled arrangement 602includes six electrodes on the anterior surface 302, six electrodes onthe inferior surface 304, and twelve peripheral connecting wireselectrically coupling each of the twelve electrodes and extendinglaterally around the periphery of the paddle body 104. A number ofsimilar laterally-extending coupled arrangements disposed along alongitudinal axis of the paddle body 104 create electrode array 134.

A coupled arrangement may use additional electrodes and peripheralconnecting wires to extend laterally around the surface of a paddlebody. For example, there can be eight electrodes and sixteen peripheralconnecting wires, ten electrodes and twenty peripheral connecting wires,twelve electrodes and peripheral twenty-four connecting wires, sixteenelectrodes and thirty-two peripheral connecting wires, or moreelectrodes and peripheral connecting wires. As will be recognized, othernumbers of electrodes and peripheral connecting wires may also be used.

Similarly, an electrode array may include variable numbers oflongitudinally-spaced coupled arrangements. For example, there can beone, two, three, four, five, six, seven, eight, nine, ten, twelve,fourteen, sixteen, twenty, twenty-four, twenty-eight, thirty-two,thirty-six, or more longitudinally-spaced coupled arrangements. As willbe recognized, other numbers of coupled arrangements may also be used.Additionally, the number of coupled arrangements disposed along alongitudinal axis of the paddle body 104 create electrode array 134.

As shown in FIGS. 3-6, multidirectional stimulation may be achievedusing one or more coupled arrangements extending around the periphery ofa paddle body. In alternate embodiments of the present invention,multidirectional stimulation may be achieved using coupled arrangementsthat include a number of electrodes on an anterior surface of a paddlebody electrically coupled to a number of electrodes on an inferiorsurface of the paddle body by transverse connecting wires that passthrough the interior of the paddle body.

FIG. 7A is a schematic cross-sectional/perspective view of a fifthembodiment of a paddle body for use in an electrical stimulation system,according to the invention. In FIG. 7A, a coupled arrangement 702includes an anterior electrode 704 disposed on anterior surface 302electrically coupled to an inferior electrode 706 disposed on inferiorsurface 304 by a transverse connecting wire 708 that extendstransversely through the paddle body 104. As discussed above, withreference to FIG. 4A, the electrodes have a much larger surface areathan the transverse connecting wires and both the electrodes and thetransverse connecting wires may be fabricated from any of a number ofsuitable conductive materials that are either flexible or nonflexible,including metals, alloys, conductive polymers, conductive carbon, andthe like, as well as combinations thereof. The conductive materials usedto fabricate the electrodes and transverse connecting wires may be thesame or different.

A paddle body may contain an electrode array that includes one or moretransversely-interconnected coupled arrangements and one or moreelectrodes that do not form a coupled arrangement. FIG. 7B is aschematic cross-sectional/perspective view of the embodiment of thepaddle body shown in FIG. 7A with electrodes in both coupledarrangements and non-coupled arrangements for use in an electricalstimulation system, according to the invention. In FIG. 7B, the coupledarrangement 702 extends transversely through paddle body 104. Likewise,a third electrode 710 disposed on the anterior surface 302 also forms acoupled arrangement 712, together with a fourth electrode (not shown inFIG. 7B) disposed on the inferior side 304 and the correspondingtransverse connecting wire. However, the paddle body 104 also includes afifth electrode 714 disposed on the anterior side 302 that is notcoupled to a corresponding electrode on the inferior side 304.

FIG. 8 is a schematic cross-sectional/perspective view of a sixthembodiment of a paddle body for use in an electrical stimulation system,according to the invention. In FIG. 8, a first coupled arrangement 802includes an anterior electrode 804 on the anterior surface 302electrically coupled with an inferior electrode 806 on the inferiorsurface 304 by transverse connecting wire 808. Similarly, a secondcoupled arrangement 810 includes an anterior electrode 812, positionedadjacent along a lateral axis from anterior electrode 804, iselectronically coupled to an inferior electrode 814, positioned adjacentalong a lateral axis from anterior electrode 806, by a transverseconnecting wire 816. A number of similar pairs of coupled arrangementsdisposed along a longitudinal axis of the paddle body 104 createelectrode array 134.

FIG. 9 is a schematic cross-sectional/perspective view of a seventhembodiment of a paddle body for use in an electrical stimulation system,according to the invention. In FIG. 9, six coupled arrangements, such ascoupled arrangement 902, include one of six laterally-spaced anteriorelectrodes, such as anterior electrode 904, coupled electronically toone of six laterally-spaced inferior electrodes opposite to the sixlaterally-spaced anterior electrodes, such as inferior electrode 906, byone of six transverse connecting wires, such as transverse connectingwire 908. A number of similar coupled arrangements disposed along alongitudinal axis of the paddle body 104 create electrode array 134.

Coupled arrangements can be created with both peripheral connectingwires and transverse connecting wires to form a lateral loop in a paddlebody. FIG. 10A is a schematic cross-sectional/perspective view of anembodiment of a coupled arrangement forming a lateral loop on a paddlebody for use in an electrical stimulation system, according to theinvention. In FIG. 10A, a coupled arrangement 1002 forming a lateralloop in a paddle body 104 includes ten peripheral connecting wires, suchas peripheral connecting wire 1004, and two transverse connecting wires,such as transverse connecting wire 1006.

Additional laterally-spaced lateral loops can be created in a paddlebody by using more coupled arrangements with fewer electrodes andconnecting wires. FIG. 10B is a schematic cross-sectional/perspectiveview of an embodiment of a coupled arrangement forming two lateral loopson a paddle body for use in an electrical stimulation system, accordingto the invention. In FIG. 10B, each of two laterally-spaced coupledarrangements 1008 and 1010 form a lateral loop in a paddle body 104using both peripheral connecting wires and transverse connecting wires.FIG. 10C is a schematic cross-sectional/perspective view of anembodiment of coupled arrangements forming three lateral loops on apaddle body for use in an electrical stimulation system, according tothe invention. In FIG. 10C, each of tree laterally-spaced coupledarrangements 1012, 1014, and 1016 form a lateral loop in a paddle body104 using both peripheral connecting wires and transverse connectingwires.

An electrode array can include various combinations of coupled andnon-coupled arrangements either with or without using one or morelateral loops of either uniform or non-uniform sizes electricallycoupled with peripheral connecting wires and/or transverse connectingwires. FIG. 11 is a schematic view of an embodiment of a paddle bodywith various coupled arrangements and non-coupled arrangements for usein an electrical stimulation system, according to the invention. In FIG.11, the electrode array 134 includes two differently-sized coupledarrangements 1102 and 1104 forming lateral loops, one coupledarrangement 1106 with electrodes disposed only on the anterior surface302, and six non-coupled electrodes 1108. In various other embodiments,different combinations of coupled and non-coupled arrangements eitherwith or without using one or more lateral loops of either uniform ornon-uniform sizes electrically coupled with peripheral connecting wiresand/or transverse connecting wires can be utilized in an electrode arrayon a paddle body.

Appropriate electrically-coupled electrodes can be selected to stimulatea desired tissue region. For example, selection of the electrodes toprovide electrical stimulation can be made by experimentation todetermine which electrodes best stimulate the desired tissue. Variouscombinations of electrodes may be tested, for example, with a patientproviding responses regarding the effects of stimulation of eachparticular combination of electrodes or the effect of the electricalstimulation can be observed instrumentally and/or visually. Note that anelectrode configuration on a paddle body that includes both peripherallyand transversely coupled electrodes can provide a vast number ofpossible simultaneous stimulation locations.

It should be apparent that increasing the number of electrodes disposedlaterally around the circumference of a paddle body increases theflexibility of a paddle lead when the materials used to fabricate thepaddle body are more flexible than the materials used to fabricate theelectrodes. Additional methods of increasing flexibility may also beused in tandem with the embodiments described above, including use offlexible materials and reducing the size of one or more electrodesdisposed on a paddle lead.

FIG. 12 is a schematic overview of one embodiment of components of astimulation system 1200 including an electronic subassembly 1210disposed within a control module. It will be understood that thestimulation system can include more, fewer, or different components andcan have a variety of different configurations including thoseconfigurations disclosed in the stimulator references cited herein.

Some of the components (for example, power source 1212, antenna 1218,receiver 1202, and processor 1204) of the stimulation system can bepositioned on one or more circuit boards of similar carriers within ahousing of an implantable pulse generator, if desired. Any power source1212 can be used including, for example, a battery such as a primarybattery or rechargeable battery. Examples of other power sources includesuper capacitors, nuclear or atomic batteries, mechanical resonators,infrared collectors, thermally-powered energy sources, flexural poweredenergy sources, bioenergy power sources, fuel cells, bioelectric cells,osmotic pressure pumps, and the like including the power sourcesdescribed in U.S. Patent Application publication No. 2004/0059392, nowU.S. Pat. No. 7,437,193, issued on Oct. 14, 2008, incorporated herein byreference.

As another alternative, power can be supplied by an external powersource through inductive coupling via the optional antenna 1218 or asecondary antenna. The external power source can be in a device that ismounted on the skin of the user or in a unit that is provided near theuser on a permanent or periodic basis.

If the power source 1212 is a rechargeable battery, the battery may berecharged using the optional antenna 1218, if desired. Power can beprovided to the battery for recharging by inductively coupling thebattery through the antenna to a recharging unit 1216 external to theuser. Examples of such arrangements can be found in the referencesidentified above.

In one embodiment, electrical current is emitted by the electrodes 134on the paddle or lead body to stimulate nerve fibers, muscle fibers, orother body tissues near the stimulation system. A processor 1204 isgenerally included to control the timing and electrical characteristicsof the stimulation system. For example, the processor can, if desired,control one or more of the timing, frequency, strength, duration, andwaveform of the pulses. In addition, the processor 1204 can select whichelectrodes can be used to provide stimulation, if desired. In someembodiments, the processor may select which electrode(s) are cathodesand which electrode(s) are anodes. In some embodiments, the processormay be used to identify which electrodes provide the most usefulstimulation of the desired tissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 1208 that, for example, allow modificationof pulse characteristics. In the illustrated embodiment, the processor1204 is coupled to a receiver 1202 which, in turn, is coupled to theoptional antenna 1218. This allows the processor to receive instructionsfrom an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 1218 is capable of receiving signals(e.g., RF signals) from an external telemetry unit 1206 which isprogrammed by a programming unit 1208. The programming unit 1208 can beexternal to, or part of, the telemetry unit 1206. The telemetry unit1206 can be a device that is worn on the skin of the user or can becarried by the user and can have a form similar to a pager, cellularphone, or remote control, if desired. As another alternative, thetelemetry unit may not be worn or carried by the user but may only beavailable at a home station or at a clinician's office. The programmingunit 1208 can be any unit that can provide information to the telemetryunit for transmission to the stimulation system. The programming unit1208 can be part of the telemetry unit 1206 or can provide signals orinformation to the telemetry unit via a wireless or wired connection.One example of a suitable programming unit is a computer operated by theuser or clinician to send signals to the telemetry unit.

The signals sent to the processor 1204 via the antenna 1218 and receiver1202 can be used to modify or otherwise direct the operation of thestimulation system. For example, the signals may be used to modify thepulses of the stimulation system such as modifying one or more of pulseduration, pulse frequency, pulse waveform, and pulse strength. Thesignals may also direct the stimulation system to cease operation, tostart operation, to start charging the battery, or to stop charging thebattery. In other embodiments, the stimulation system does not includean antenna 1218 or receiver 1202 and the processor 1204 operates asprogrammed.

Optionally, the stimulation system may include a transmitter (not shown)coupled to the processor and antenna for transmitting signals back tothe telemetry unit 1206 or another unit capable of receiving thesignals. For example, the stimulation system may transmit signalsindicating whether the stimulation system is operating properly or notor indicating when the battery needs to be charged or the level ofcharge in the battery. The processor may also be capable of transmittinginformation about the pulse characteristics so that a user or cliniciancan determine or verify the characteristics.

A paddle body may be formed in the desired shape by any number ofprocesses including, for example, molding (including injection molding),casting, and the like. Electrodes and connecting wires can be disposedonto or within a paddle body either prior to or subsequent to a moldingor casting process.

The above specification, examples and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

1. A paddle lead, comprising: a paddle body having a first majorsurface, an opposing second major surface, and a transversecircumference; a plurality of electrodes disposed on the paddle body,the plurality of electrodes comprising a first electrode and a secondelectrode disposed laterally from one another along the first majorsurface of the paddle body, and a third electrode and a fourth electrodedisposed laterally from one another along the second major surface ofthe paddle body; and a plurality of connecting wires, wherein a firstconnecting wire of the plurality of connecting wires electricallycouples the first electrode to the second electrode, wherein a secondconnecting wire of the plurality of connecting wires electricallycouples the third electrode to the fourth electrode, and wherein atleast one of the first or second connecting wires is a peripheralconnecting wire that is disposed on at least one of the first majorsurface or the second major surface of the paddle body.
 2. The paddlelead of claim 1, wherein the plurality of electrodes are disposed insimilar orientations on each of the first major surface and the secondmajor surface.
 3. The paddle lead of claim 1, wherein at least one ofthe connecting wires directly connects one of the plurality ofelectrodes to another of the plurality of electrodes.
 4. The paddle leadof claim 1, wherein the paddle body is flexible.
 5. The paddle lead ofclaim 1, wherein the paddle body is fabricated from a non-conductive,biocompatible material suitable for subcutaneous implantation.
 6. Thepaddle lead of claim 1, wherein the first and second electrodes areaxially aligned with the third and fourth electrodes along a length ofthe paddle body.
 7. The paddle lead of claim 1, wherein the plurality ofelectrodes further comprises a fifth electrode disposed laterally fromthe first electrode and the second electrode along the first majorsurface of the paddle body.
 8. The paddle lead of claim 1, wherein theplurality of electrodes further comprises a sixth electrode disposedlaterally from the third electrode and the fourth electrode along thesecond major surface of the paddle body.
 9. The paddle lead of claim 1,wherein the paddle body is formed from a non-conductive material. 10.The paddle lead of claim 1, wherein the plurality of connecting wirescomprises a third connecting wire electrically coupling the firstelectrode of the first major surface to the third electrode of thesecond major surface.
 11. The paddle lead of claim 10, wherein the thirdconnecting wire is a peripheral connecting wire that is disposed on aportion of the first major surface and a portion of the second majorsurface.
 12. A stimulation system, comprising: the paddle lead of claim1; and a control module coupleable to the paddle lead.
 13. A paddlelead, comprising: a lead body for coupling the paddle lead to one ormore external devices; and a paddle body distal to the lead body, thepaddle body having a first major surface and an opposing second majorsurface, the paddle body comprising a plurality of electrodes disposedon the paddle body such that at least two of the plurality of electrodesare laterally disposed from one another on the first major surface ofthe paddle body and at least two of the plurality of electrodes arelaterally disposed from one another on the second major surface of thepaddle body, wherein at least some of the laterally-disposed electrodesform at least one lateral loop of electrically coupled electrodesdisposed around at least a portion of a transverse circumference of thepaddle body, each of the at least one lateral loops comprising at leasttwo of the laterally-disposed electrodes of the first major surface, atleast two of the laterally-disposed electrodes of the second majorsurface, and a plurality of connecting wires, a first connecting wire ofthe plurality of connecting wires electrically coupling together the atleast two laterally-disposed electrodes of the first major surface, asecond connecting wire of the plurality of connecting wires electricallycoupling together the at least two laterally-disposed electrodes of thesecond major surface, and at least one of the plurality of connectingwires electrically coupling together one of the at least twolaterally-disposed electrodes of the first major surface with one of theat least two laterally-disposed electrodes of the second major surface;wherein at least one of the first or second connecting wires is aperipheral connecting wire that is disposed on at least one of the firstmajor surface or the second major surface of the paddle body.
 14. Thepaddle lead of claim 13, wherein at least one of the connecting wires isa transverse connecting wire that is disposed within the paddle body.15. The paddle lead of claim 13, wherein the paddle lead comprises atleast two laterally-disposed lateral loops.
 16. The paddle lead of claim13, wherein the paddle body is formed from a non-conductive material.